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510(k) K153577

FREND Testosterone Test System by Nanoentek USA, Inc. — Product Code CDZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 14, 2016
Date Received
December 15, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Testosterones And Dihydrotestosterone
Device Class
Class I
Regulation Number
862.1680
Review Panel
CH
Submission Type

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